MAUDE Adverse Event Report: RESPIRONICS, INC. RESPIRONICS; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE

Model Number V60

Device Problem Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/01/2023

Event Type  malfunction  

Event Description

Philips received a complaint by the customer on the v60 indicating that there was an abnormal alarm.The device was in use on a patient at the time the reported issue was discovered; however, there was no reported harm to the patient or user.Investigation is ongoing.

Manufacturer Narrative

E: (b)(6).

Manufacturer Narrative

H10: the customer reported that an abnormal alarm occurred.Per good faith effort (gfe response), the authorized service provider (asp) engineer confirmed the reported issue but could not describe the reported ¿abnormal alarm¿ issue in more detail.The asp engineer also stated that no repairs were completed as the customer declined service and repair and went with a third-party vendor.No additional details regarding the reported issue and resolution are available; however, the asp engineer verified that the device was repaired, successfully passed performance specification testing and was returned to service.The investigation concludes that no further action is required at this time.The device remains at the customer site.If the decision is made to have the device evaluated and repaired, a new service order will be opened and will be captured through philip's normal complaint procedure.

Manufacturer Narrative

H10 per gfe response, the asp engineer confirmed the reported issue and stated that the device was not in patient use at the time the reported issue was discovered.Investigation remains ongoing.

• Brand Name: RESPIRONICS
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 1001 murry ridge lane; murrysville, PA 15668 ; 7247330200
• MDR Report Key: 18278003
• MDR Text Key: 329863413
• Report Number: 2518422-2023-33960
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K102985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V60
• Device Catalogue Number: 1076716
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/06/2023
• Supplement Dates Manufacturer Received: 12/12/2023; 12/18/2023
• Supplement Dates FDA Received: 12/15/2023; 12/20/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1